Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first office action in response to the above identified patent application filed on 09/29/2023. Claims 1-16 are currently pending and being examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the phrase "can ” in lines 3 and 21 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are in fact performed by the invention, and are part of the invention or if such recitation is just a possible result that may or may not happen. Appropriate correction is required.
Regarding Claim 3, the phrase "can ” in line 3 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are in fact performed by the invention, and are part of the invention or if such recitation is just a possible result that may or may not happen. Appropriate correction is required.
Regarding Claim 5, the phrase "can ” in lines 9 and 12 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are in fact performed by the invention, and are part of the invention or if such recitation is just a possible result that may or may not happen. Appropriate correction is required.
Regarding Claim 7, the phrase "can be” in line 6 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are in fact performed by the invention, and are part of the invention or if such recitation is just a possible result that may or may not happen. Appropriate correction is required.
Regarding Claim 11, the phrase "can ” in line 3 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are in fact performed by the invention, and are part of the invention or if such recitation is just a possible result that may or may not happen. Appropriate correction is required.
Regarding Claim 13, the phrase "can be” in line 6 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are in fact performed by the invention, and are part of the invention or if such recitation is just a possible result that may or may not happen. Appropriate correction is required.
Claims 2, 4, 6, 8-10, 12 and 14-16 depend from Claim 1 and are rejected accordingly
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 9-11 and 14-16 are rejected under 35 U.S.C. 102a1 as being anticipated by Egan (US 2021/0283344).
In regards to Independent Claim 1, and with particular reference to Figures 5-7, Egan discloses a needle assembly comprising:
a needle support portion (46, 48 in figure 5) in which a hollow needle 28 through which a medicinal solution can flow is supported (medicinal solution from delivery pen 2; par. 39);
a movable needle cover portion 14 that is movable in an opening portion 26 of a casing (the casing can be interpreted as 36 alone or combined 34 and 36; with either interpretation the claim is anticipated) such that an injection-side end portion of the medicinal solution of the needle protrudes outward in use (as shown in figure 6);
a tubular portion 96 arranged on the needle support portion (46/48) and partially abuttable (abutting with inclined/angled surface 104) with the movable needle cover portion 14; and
a biasing portion 64 configured to bias the movable needle cover portion 14 in a direction opposite (pushing up 14; direction when the spring is extended as shown in figure 7) to one direction (pushing down 14 into the casing 36; compressing the spring as shown in figures 5-6) along with movement of the movable needle cover portion 14 in the one direction,
the needle support portion (46/48), the movable needle cover portion 14, the tubular portion 96, and the biasing portion 64 being each configured to be at least partially accommodated in the casing (the casing can be interpreted as 36 alone or combined 34 and 36; with either interpretation the claim is anticipated) having the opening portion 26,
wherein at least the movable needle cover portion 14 abuts (abutting/in contact with inclined/angled surface 104 and then with surface 100; as shown in figures 5 and 6) on the tubular portion 96 by the movement of the movable needle cover portion 14 in the one direction (pushing down 14) to axially rotate from a predetermined position (shown in figure 5) before movement to another position (shown in figure 6), so that the movable needle cover portion 14 after the axial rotation is movable in the opposite direction (pushing up 14; refer to figure 7) by the biasing portion 64, and
wherein the movable needle cover portion 14 after the axial rotation, which has completed the movement in the opposite direction (refer to figure 7), can be locked to the casing (locked to the casing 36 or the casing 34/36 via tabs 60).
Regarding dependent Claim 2, Egan discloses wherein the tubular portion 96 is integrally movable (as shown in figure 7, the gripping force between the movable needle portion 14 and the tubular portion 96 enables separation of the tubular portion 96 from the needle support portion 46/48; par. 51) with the movable needle cover portion 14 after the axial rotation.
Regarding dependent Claim 3, Egan discloses wherein when the movement of the movable needle cover portion 14 in the opposite direction is completed, a part of the tubular portion 96 integrally movable with the movable needle cover portion 14 can protrude (as shown in figure 7) from at least the opening portion 26 of the casing 36/34.
Regarding dependent Claim 4, Egan discloses wherein the movable needle cover portion 14 is transparent or translucent (abstract teaches the marker 94/96 is visible through the movable needle cover 14, thus implying it is transparent or translucent), and the tubular portion 94/96 is a colored marker portion (has a contrasting color; par. 49 ) for determining whether the needle has been used (as explained in par. 49).
Regarding dependent Claim 5, Egan discloses wherein the movable needle cover portion 14 has a substantially cylindrical shape (refer to figures 1, 5), and the tubular portion 96 having a first tubular portion projection portion (portion of element 96 in contact with a portion of element 14, refer to figure 7) on an outer side surface is positioned in an inner region of the movable needle cover portion having the cylindrical shape (referring to figures 5-7, the portion of element 96 that is into element 14), and
wherein at least one of a side surface lower end portion (portion of element 14 having the surface 104) of the movable needle cover portion 14 and the first tubular portion projection portion has an inclined surface 104 that can abut on each other (refer to figure 5), and the side surface lower end portion of the movable needle cover portion 14 abuts on the first tubular portion projection portion along with the movement of the movable needle cover portion in the one direction (as shown in figures 5 and 6; a portion of the element 14 abuts/in contact with a portion of element 96), whereby the movable needle cover portion can axially rotate.
Regarding dependent Claim 6, Egan discloses wherein only the side surface lower end portion of the movable needle cover portion has the inclined surface 104, and the first tubular portion projection portion has a substantially circular shape in a cross-sectional view or a side view, as shown in figure 7.
Regarding dependent Claim 9, Egan discloses wherein the movable needle cover portion 14 includes a first needle cover portion projection portion (legs 56 forming the spring receiving channel 102) locally formed on an outer side surface (outer in comparison with portion 100 of the element 14), and the biasing portion 64 is arranged between the needle support portion 46/48 and the first needle cover portion projection portion 56, refer to figures 5, 6.
Regarding dependent Claim 10, Egan discloses wherein the movable needle cover portion 14 after the axial rotation, which has been pushed down and moved in the one direction, is movable in the opposite direction via the first needle cover portion projection portion 56 by the biasing portion 64, as shown in figures 5-7.
Regarding dependent Claim 11, Egan discloses wherein the first needle cover portion projection portion 56 of the movable needle cover portion 14 after the axial rotation can be locked to a locked portion formed on a side surface of the casing (locked to the casing 36 or the casing 34/36 via tabs 60).
Regarding dependent Claim 14, Egan discloses wherein the needle assembly is replaceably attached to a pen injector 2 including the medicinal solution therein (medicinal solution from delivery pen 2; par. 39);.
Regarding dependent Claim 15, Egan discloses wherein the needle support portion 46/48 includes a base portion 46, the base portion being capable of accommodating therein a non-injection-side end portion of the needle opposite to the injection-side end portion of the medicinal solution, as shown in figures 5-7.
Regarding dependent Claim 16, Egan discloses wherein the needle support portion 46/48 further includes an extending portion 48 having the needle fixedly supported on the base portion 46 therein, and the extending portion of the needle support portion is movable inside the movable needle cover portion 14, as shown in figures 5-7.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Egan.
Egan teaches the invention as claimed and as disclosed including the first needle cover portion 56.
Egan does not teach the first needle cover portion projection portion 56 having a wing shape.
It has been held that the configuration of the shape of an apparatus is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the first needle cover portion projection portion in Egan to have wing shape since it has been held that the configuration of the shape of an apparatus is a matter of choice absent persuasive evidence that the particular configuration of the claimed apparatus is significant. See MPEP 2144.04 IV(B).
Further, the Examiner additionally notes that "[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438 (CCPA 1929); MPEP 2144.05(II)(A).
Allowable Subject Matter
Claims 7, 8 and 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H RODRIGUEZ whose telephone number is (571)272-4831. The examiner can normally be reached Mon-Fri 8:30-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached at 571-270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H Rodriguez/Primary Examiner, Art Unit 3741